Common use of Development Responsibilities Clause in Contracts

Development Responsibilities. Unless the Parties agree in writing upon an alternative allocation of responsibilities, the Parties shall have the following rights and obligations with respect to the conduct of the Studies: (a) BMS and Pfizer Responsibilities. BMS and/or Pfizer shall be responsible for: (i) manufacturing and supplying cGMP-grade Apixaban required for the Studies (with such manufacturing to be undertaken by BMS pursuant to Article 4); (ii) providing Portola with the right of reference to regulatory materials of Apixaban that are reasonably necessary to conduct the Studies and to facilitate the Regulatory Approval for PRT064445 use as an antidote for Apixaban; (iii) [*] the Preclinical Studies directed by Regulatory Authorities or otherwise agreed upon by the JCC; (iv) [*] protocols and amendments relating to the use of Apixaban in the Clinical Trial; (v) [*] the resulting Clinical Trial data relating to Apixaban; (vi) providing [*] with respect to [*], which [*] may be provided by BMS or Pfizer [*]; (vii) [*] management of the Clinical Trial; (viii) performing the regulatory activities as set forth in Section 6.1(c); and (ix) performing such Preclinical Studies as the JCC (by mutual agreement) assigns to BMS or Pfizer and that BMS or Pfizer agrees to carry out (it being understood that the Clinical Study shall remain the responsibility of Portola).